If you’ve ever asked about hormone therapy and felt your provider stiffen up like you just suggested drinking bleach, you’re not alone.
For years, hormone labels have been loud. Like, “danger!” loud.
And women paid the price.
Here’s the good news: the FDA is updating hormone therapy warning labels across multiple products, not just vaginal estrogen. The most dramatic boxed warnings about heart disease, breast cancer, and “probable dementia” are being removed from certain menopausal hormone therapy products as labels are updated.
If you are thinking, “About time,” same here.
Now let’s talk about what happened, why it matters, and how you can use this moment to get the care you need.
First, where did those scary warning labels come from?
A big part of this story starts with the Women’s Health Initiative (WHI) study in the early 2000s.
When the WHI results hit the news, the message that traveled fastest was simple: estrogen is dangerous because it causes breast cancer.
That message turned into fear and the brakes were immediately put on hormone prescribing. Women were told to just deal with symptoms like hot flashes, insomnia, mood swings, brain fog, and painful sex.
Here is the problem.
The WHI findings, once re-analyzed some years later, showed that synthetic progestins were the problem and that women in the estrogen-only group actually had a protective effect against cancer. And the study only used oral forms of hormones, which we now know carry more possible side effects than topical forms. Add to this that the wrong patients were studied (older and way past menopause). Regardless, hormones were labeled with a “black box” regarding heart attack, cancer risk and stroke.
Cue the panic.
A boxed warning does not say, “This is complicated, let’s talk.” It screams, “Nope.”
And that is how we got stuck in the “HRT panic era.”
So what’s now?
In November 2025, federal health officials announced the FDA was moving to remove misleading boxed warnings from menopausal hormone therapy products and update labeling to reflect current evidence.
Then on February 12, 2026, the FDA approved labeling changes for a first group of products spanning different categories, including systemic hormones and a vaginal product.
To be clear, the FDA is not saying hormone therapy has zero risks.
The FDA is saying the old warning style was too broad, too scary, and not balanced for how menopause care is actually practiced today.
Also important: endometrial cancer risk warnings still matter for systemic estrogen-alone therapy. If you have a uterus, you need uterine protection when using systemic estrogen. That has not changed.
Why this matters for real women
Because fear has consequences.
I see women every week who:
- have not slept through the night in months
- feel anxious for no reason
- do not recognize themselves
- have painful sex and feel like nobody cares
- are gaining weight even though they are “doing everything right”
- are terrified of hormones, but also terrified of living like this forever
And too many are still getting brushed off with:
- “Your labs are normal.”
- “It’s just aging.”
- “Try melatonin.”
- “Manage your stress.”
- “Here’s an antidepressant.”
Listen. Nonhormonal options can be helpful for some women. I recommend them for women who really don’t want to go down the hormone road.
But refusing to even discuss hormone therapy because of an outdated fear story is not good medicine.
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What is different now in hormone therapy conversations?
Here is what a better conversation includes:
Timing matters.
Starting hormone therapy years after menopause can be different from starting closer to the transition.
Route matters.
Oral hormones, patches, gels, and vaginal estrogen are not the same thing.
Dose matters.
Hormone therapy should be individualized according to a woman’s goals.
You matter.
Your health history, your symptoms, and your risk factors should drive the decision.
This is exactly why the one-size warning labels were such a mess.
The education gap is still the real problem
Label changes are helpful, but they do not automatically fix the system.
Many clinicians got trained during the “avoid hormones” era. Some are still practicing like it is 2002. And many women have been scared by years of scary headlines and poorly explained risks.
So how do we close the gap?
- We teach menopause care like it matters. Because it does.
- We stop using the label as a shortcut for real counseling.
- We give women simple, clear scripts so they can advocate for themselves.
- We practice shared decision making.
Which brings us to the most important part.
What to say to your healthcare provider (take this to your next visit)
You do not need to be rude and demanding. You do need to be clear.
1) Lead with impact
Try: “My symptoms are affecting my sleep and work. I need a real treatment plan.”
2) Ask for an individualized risk review
Say: “Can we discuss my personal risks and benefits, not a general warning label?”
3) Ask about choices, not just yes or no
Ask: “What options are on the table? Hormonal and nonhormonal. What are the pros and cons of each for me?”
4) If you have a uterus, say this out loud
“I have a uterus. If we use systemic estrogen, what is the plan to protect the lining?”
If they cannot answer clearly, that is a red flag.
5) If they refuse, ask for a referral and documentation
Try: “If you are not comfortable prescribing, can you document why and refer me to a clinician who specializes in menopause care?”
This is not “being difficult.” This is you getting appropriate care.
6) Use the FDA update as a conversation opener
Say: “I saw the FDA is updating hormone therapy labels and removing broad boxed warning language. Can we talk about how that applies to me?”
That is factual. That is calm. That is powerful.
If you want to walk into your appointment prepared (and not get steamrolled), book a Let’s Talk Consultation (45 minutes).
This is not a free discovery call. It’s a paid strategy session where you leave with understanding of your body, clear next steps and a short script for your visit.
https://drannagarrett.com/lets-talk/
One more thing: stop waiting for permission to feel better
Some women do not want hormone therapy. Some cannot use it. That’s fine.
But if you are suffering and you are a reasonable candidate, you deserve a real conversation. Not fear. Not dismissal. Not “just push through.”
Bottom line: the label update is a step in the right direction. But the real win is women learning to advocate for themselves, and clinicians getting up to date.
You are not “too young.” You are not “too old.” You are not broken.
You are informed. And you are allowed to ask for more.
Ready to stop guessing? Book your Let’s Talk Consultation (45 minutes) here:
https://drannagarrett.com/lets-talk/
References
American College of Obstetricians and Gynecologists. (2025, November 10). ACOG president says label change on estrogen will increase access to hormone therapy. https://www.acog.org/news/news-releases/2025/11/acog-president-says-label-change-on-estrogen-will-increase-access-to-hormone-therapy
Associated Press. (2025, November 10). The FDA removes a long-standing warning from hormone-based menopause drugs. https://apnews.com/article/menopause-hormones-warning-fda-drugs-pills-women-f26a8208fd3f5174ec96d61140439561
Food and Drug Administration. (2026, February 12). FDA approves labeling changes to menopausal hormone therapy products. https://www.fda.gov/news-events/press-announcements/fda-approves-labeling-changes-menopausal-hormone-therapy-products
Makary, M. A. (2026). Updated labeling for menopausal hormone therapy. JAMA. https://jamanetwork.com/journals/jama/fullarticle/2841321
Reuters. (2026, February 12). US FDA approves labeling changes to menopausal hormone therapy products. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-labeling-changes-menopausal-hormone-therapy-products-2026-02-12/
U.S. Department of Health & Human Services. (2025, November 10). Fact sheet: FDA initiates removal of “black box” warnings from menopausal hormone replacement therapy products. https://www.hhs.gov/press-room/fact-sheet-fda-initiates-removal-of-black-box-warnings-from-menopausal-hormone-replacement-therapy-products.html
Dr. Anna Garrett is a menopause expert and Doctor of Pharmacy. She helps women who are struggling with symptoms of perimenopause and menopause find natural hormone balancing solutions so they can rock their mojo through midlife and beyond. Dr. Anna is the author of Perimenopause: The Savvy Sister’s Guide to Hormone Harmony. Order your copy at www.perimenopausebook.com.
Dr. Anna is available for 1-1 consultations. Find out more at www.drannagarrett.com/lets-
